Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up (UMF)

Stryker

Status: Enrolling

Conditions: Zygomatic Fractures; Maxilla Fractures; Facial Fractures; Orbital Fractures

Treatments: Device: Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System

Study type: Observational

Funder types: Industry

Identifiers

NCT07245719

Universal CMF System _2023_01

Details and patient eligibility

About

A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.

Full description

This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of the Stryker Universal System when used in a clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. Based on a non-inferiority study power calculation a minimum of 120 patients will be enrolled in the study. Additional patients may be enrolled up to 150 subjects depending on site enrolment rate and patient availability. Up to 2 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Skeletally mature patients at the time of surgery.
2. Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice.
3. Patients for whom data on the primary outcome variable is available.
4. Patients with data available from follow-up visits.

Exclusion criteria

1. Patients with active infections at the time of surgery.
2. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
3. Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices.
4. Patients who underwent secondary reconstructions with non-secondary reconstruction plates
5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.